EFFICIENCY OF LONG ACTING OLANZAPINE INJECTION IN SCHIZOPHRENIA
- Conditions
- Health Condition 1: null- Diagnosed with schizophrenia
- Registration Number
- CTRI/2017/05/008586
- Lead Sponsor
- Dr Varun S Mehta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
1. Diagnosis of Schizophrenia according to Diagnostic Criteria for Research of International Classification of Diseases -tenth edition (ICD-10)
2. Documented reduction of 50 % from the baseline score in PANSS & BPRS within 4 weeks of treatment with oral olanzapine
3. Patients with illness duration of >2 years
4. Patients who had at least one relapse in previous one year due to non-adherence
5. Patients who are anti-psychotic drug-free for last 4 weeks (oral) or 8 weeks (depot preparation)
6. Patients who give written informed consent.
1. Past history of documented non-response to Olanzapine
2. Past history of use of olanzapine Long-Acting Injection
3. History of significant head injury or epilepsy
4.Any comorbid psychiatric illness or substance use in dependence pattern except nicotine or caffeine
5.Known case of Hypertension, Diabetes mellitus or Dyslipidemia
6. Body mass index greater than or equal to 30 kg/m2
7.Not willing to give consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in the scores of the Positive and Negative Symptom Scale (PANSS) <br/ ><br>2. Changes in the scores of Brief Psychiatric Rating Scale (BPRS) <br/ ><br>3. Chnage in the Clinical Global Impression Scale (CGI) <br/ ><br>4. Change in the clinical parameters of Blood Pressure, Body Mass Index (BMI) and Waist Circumference <br/ ><br>4.Change in the laboratory parameters namely Fasting Glucose, Serum Triglycerides and HDL - CTimepoint: 1. The clinical rating scales (PANSS,BPRS,CGI) will be applied at baseline and weekly till 6 weeks <br/ ><br>2. The clinical and laboratory parameters will be measured at baseline and then at the end of six weeks
- Secondary Outcome Measures
Name Time Method OT APPLICABLETimepoint: NOT APPLICABLE